510(k) · Cleared
ClearedTrufill DCS Orbit Detachable Coil System Line Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Neurovascular, Inc. · HCG Device, Neurovascular Embolization
Cleared on Dec 15, 2005 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 15, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK053197 Trufill DCS Orbit Detachable Coil System Line ExtensionCordis Neurovascular, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK123560 Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS…Codman & Shurtleff, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K123560Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable…Codman & Shurtleff, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053197 | Trufill DCS Orbit Detachable Coil System Line Extension | Cordis Neurovascular, Inc. | 2005 | — |
| +1 | K123560 | Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit… | Codman & Shurtleff, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HCG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123560 | Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable… | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123560 (Codman & Shurtleff, Inc., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
MAUDE reports naming product code HCG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
What is it indicated for?
The TRUFILL DCS ORBIT TM Detachable Coil is indicated for embolizing certain intracranial aneurysms that. because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be: I) very high-risk for management by traditional operative techniques 2) inoperable and for embolizing other vascular malformations such as arteriovenous mallonnations and arteFioveCfous tistulaC of the neurovasculature. The TRUFILL DCS ORBII M T Detachable Coil is also intended for arterial and venous enbolizations in the peripheral vasculature. The TRUFILLJ' DCS SyTinge is indicated for use with the TRUPILL> family of Detachable Coils.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K053197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053197: Trufill DCS Orbit Detachable Coil System Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053197
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026